WSR 25-08-072
PERMANENT RULES
DEPARTMENT OF HEALTH
(Pharmacy Quality Assurance Commission)
[Filed April 1, 2025, 2:54 p.m., effective May 2, 2025]
Effective Date of Rule: Thirty-one days after filing.
Purpose: Medication assistance; the purpose of the adopted rule is to make permanent and update regulatory guidelines around the practice of medication assistance under the pharmacy quality assurance commission's (commission) and the department of health's (department) jurisdiction. The adopted rules establish criteria for medication assistance in community-based and in-home care settings in accordance with chapter
69.41 RCW. The definition for medication assistance provided in RCW
69.41.010(15) states:
"Medication assistance" means assistance rendered by a nonpractitioner to an individual residing in a community-based care setting or in-home care setting to facilitate the individual's self-administration of a legend drug or controlled substance. It includes reminding or coaching the individual to take their medication, handing the medication container to the individual, opening the individual's medication container, using an enabler, or placing the medication in the individual's hand, handing an individual their prefilled insulin syringe, transferring an individual's medication from one container to another in order to prepare an individual dose, and medication alteration, provided the individual is aware their medication is being altered.
When the adopted rule becomes effective it will replace the existing emergency rule. The adopted rule is significantly different than the current emergency rule that is in effect. However, the commission and department believe the adopted rule best reflects the current standard of care for medication assistance in community-based and in-home care settings.
Citation of Rules Affected by this Order: New WAC 246-945-710, 246-945-712, 246-945-714, 246-945-716, and 246-945-718.
Adopted under notice filed as WSR 24-21-154 on October 22, 2024.
Changes Other than Editing from Proposed to Adopted Version: No changes other than editing. The commission made one editing change where an instance of the word "and" in WAC 246-945-712(6) was changed to "or" for the purpose of clarifying the settings in which medications used in the provision of medication assistance may be prescribed.
A final cost-benefit analysis is available by contacting Joshua Munroe, P.O. Box 47852, Olympia, WA 98504-7852, phone 360-502-5058, fax 360-236-2901, TTY 711, email PharmacyRules@doh.wa.gov.
Number of Sections Adopted in Order to Comply with Federal Statute: New 0, Amended 0, Repealed 0; Federal Rules or Standards: New 0, Amended 0, Repealed 0; or Recently Enacted State Statutes: New 0, Amended 0, Repealed 0.
Number of Sections Adopted at the Request of a Nongovernmental Entity: New 0, Amended 0, Repealed 0.
Number of Sections Adopted on the Agency's own Initiative: New 5, Amended 0, Repealed 0.
Number of Sections Adopted in Order to Clarify, Streamline, or Reform Agency Procedures: New 0, Amended 0, Repealed 0.
Number of Sections Adopted using Negotiated Rule Making: New 0, Amended 0, Repealed 0; Pilot Rule Making: New 0, Amended 0, Repealed 0; or Other Alternative Rule Making: New 5, Amended 0, Repealed 0.
Date Adopted: March 31, 2025.
Hawkins DeFrance, PharmD, Chair
Pharmacy Quality Assurance Commission
and Kristin Peterson, JD
Chief of Policy
for Jessica Todorovich, MS
Acting Secretary of Health
OTS-5724.4
PART 5 - MEDICATION ASSISTANCE
NEW SECTION
WAC 246-945-710Scope and applicability.
WAC 246-945-710 through 246-945-718 only apply to medication assistance rendered by a nonpractitioner to an individual residing in a community-based care setting or an in-home care setting.
NEW SECTION
WAC 246-945-712Definitions.
The definitions in this section apply to WAC 246-945-710 through 246-945-718 unless the context clearly requires otherwise:
(1) "Community-based care settings" has the same meaning as RCW
69.41.010.
(2) "Enabler" means a physical device or devices used to facilitate an individual's self-administration of a medication including, but not limited to, a medicine cup, glass, cup, spoon, bowl, prefilled insulin syringe, a specially adapted table surface, straw, piece of cloth, fabric, or the individual's hand.
(3) "Hand-over-hand administration" means a person is providing total physical assistance to an individual when administering the individual's medication.
(4) "In-home care settings" has the same meaning as RCW
69.41.010.
(5) "Individual" means a person residing in a community-based
setting or in-home care setting.
(6) "Medication" means legend drugs, including controlled substances, prescribed to an individual residing in a community-based care setting or an in-home care setting. Medication does not include oxygen.
(7) "Medication alteration" means alteration of a medication by a nonpractitioner to prepare a medication for an individual's self-administration and includes, but is not limited to, crushing tablets, cutting tablets in half, opening capsules, mixing powdered medications with foods or liquids, mixing tablets or capsules with foods or liquids, or altering an oral medication for administration via enteral tube.
(8) "Practitioner" has the same meaning as RCW
69.41.010.
NEW SECTION
WAC 246-945-714Medication assistance by nonpractitioners.
(1) An individual may receive medication assistance from nonpractitioners. Medication assistance only includes:
(a) Reminding or coaching the individual to take their medication;
(b) Handing the individual their medication container;
(c) Opening the individual's medication container;
(d) Using an enabler, except if a nonpractitioner uses the individual's hand as an enabler, the nonpractitioner may only steady or guide an individual's hand while the individual administers a medication to themselves and may not engage in "hand-over-hand" administration;
(e) Placing the individual's medication in their hand;
(f) Handing an individual their prefilled insulin syringe;
(g) The transfer of an individual's medication from one container to another container for the purpose of preparing an individual dose; or
(h) Medication alteration. An individual must be aware that their medication has been altered.
(2) A nonpractitioner shall only perform the medication assistance described in subsection (1)(g) and (h) of this section, where a practitioner has determined and communicated orally or by written direction that such medication preparation assistance is necessary and appropriate.
(3) A nonpractitioner shall not provide medication assistance to individuals that involves intravenous medications or injectable medications, except handing an individual their prefilled insulin syringes.
NEW SECTION
WAC 246-945-716Self-administration in licensed assisted living facilities.
In licensed assisted living facilities, self-administration may include situations in which an individual cannot physically self-administer medications but can accurately direct others.
NEW SECTION
WAC 246-945-718Medication assistance—Restrictions.
(1) Medication assistance must only be provided if the individual is cognitively aware they are receiving medications.
(2) Medication assistance must occur immediately prior to the individual's self-administration of the medication.
(3) If an individual is not able to administer a medication to themselves independently or with assistance, then the medication must be administered to the individual by a person legally authorized to do so.
(4) WAC 246-945-710 through 246-945-718 do not limit the rights of people with functional disabilities to self-direct care according to chapter
74.39 RCW.